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LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS

Primary Purpose

Osteoarthritis of the Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional exercise therapy
Sponsored by
Mai Mohamed Abdelkader Abdallah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Blood flow restriction training

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range from 45-60 years (Segal et al., 2015).
  • Walk with painful knee OA without assistive devices (Bryk et al., 2016).
  • Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
  • BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
  • Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)

Exclusion Criteria:

  • Severe knee OA (grade IV according to K/L classification).
  • Bilateral knee OA.
  • Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
  • Repeated treatment with steroids.
  • Secondary knee OA.
  • Received joint replacement surgery in either Knee or/and hip.
  • Cardiovascular and neuromuscular disorders
  • Diabetic patients
  • Psychiatric disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    control group (Traditional therapy group)

    Experimental group I (BFR training group)

    Experimental group II (Neuromuscular training group)

    Arm Description

    control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training

    Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.

    Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises

    Outcomes

    Primary Outcome Measures

    Muscle strength
    Hand-Held Dynamometer for measuring muscle strength

    Secondary Outcome Measures

    Knee joint function
    Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function

    Full Information

    First Posted
    October 19, 2020
    Last Updated
    October 19, 2020
    Sponsor
    Mai Mohamed Abdelkader Abdallah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04600661
    Brief Title
    LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
    Official Title
    LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2021 (Anticipated)
    Primary Completion Date
    June 15, 2021 (Anticipated)
    Study Completion Date
    September 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mai Mohamed Abdelkader Abdallah

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
    Detailed Description
    PURPOSE: This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy. BACKGROUND: Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016). HYPOTHESES: There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA. There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA. There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA. RESEARCH QUESTION: Does blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Knee
    Keywords
    Blood flow restriction training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups using opaque, sealed envelopes, each containing the name of one of the groups. Each patient will sign an informed consent before starting the study (Appendix III). All patients will be referred by the orthopedic surgeon who will diagnose knee OA based on clinical and radiological examination. The investigator will be blinded
    Allocation
    Randomized
    Enrollment
    63 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group (Traditional therapy group)
    Arm Type
    Experimental
    Arm Description
    control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training
    Arm Title
    Experimental group I (BFR training group)
    Arm Type
    Experimental
    Arm Description
    Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.
    Arm Title
    Experimental group II (Neuromuscular training group)
    Arm Type
    Experimental
    Arm Description
    Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
    Intervention Type
    Other
    Intervention Name(s)
    Traditional exercise therapy
    Other Intervention Name(s)
    Blood flow restriction training
    Intervention Description
    Neuromuscular training
    Primary Outcome Measure Information:
    Title
    Muscle strength
    Description
    Hand-Held Dynamometer for measuring muscle strength
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Knee joint function
    Description
    Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age range from 45-60 years (Segal et al., 2015). Walk with painful knee OA without assistive devices (Bryk et al., 2016). Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016). BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016). Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008) Exclusion Criteria: Severe knee OA (grade IV according to K/L classification). Bilateral knee OA. Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee. Repeated treatment with steroids. Secondary knee OA. Received joint replacement surgery in either Knee or/and hip. Cardiovascular and neuromuscular disorders Diabetic patients Psychiatric disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai M Abdelkader
    Phone
    +201094355573
    Email
    mai.abdelkader@pua.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Enas Fawzy, Prof
    Phone
    +2 01127867507
    Email
    Enas.fawzy@pt.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26971109
    Citation
    Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
    Results Reference
    background

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    LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS

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